Onvansertib

FN Media Group News Commentary PALM BEACH, Fla., May 9, 2024 /PRNewswire/ -- The incidence of pancreatic cancer is increasing globally, which is driving the growth of the market. As of 2023, the American Cancer Society predicts that 64,050 Americans will be diagnosed with pancreatic cancer. It is estimated that 50,550 people will die from pancreatic cancer (26,620 men and 23,930 women). Pancreatic cancer is an aggressive form of cancer, and it is often not detected until it is in an advanced stage. Additionally, the treatment options for pancreatic cancer are limited, and the survival rate is low. These factors are contributing to the rise in pancreatic cancer cases, which in turn is driving the growth of the pancreatic cancer market. A recent report from Research Nester projected that the global pancreatic cancer market size is slated to expand at ~18% CAGR between 2024 and 2036. The market is poised to garner a revenue of USD 36 billion by the end of 2036, up from a revenue of ~USD 6 billion in the year 2023. The report said: "Advancements in diagnosis and treatment options for pancreatic cancer are also driving the growth of the market. As researchers gain a better understanding of the different types of pancreatic cancer, they are developing more targeted treatments that are more likely to be effective with fewer side effects. Additionally, new treatment options, such as immunotherapy and targeted therapies, are improving patient outcomes and extending survival rates." Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Zai Lab Limited (NASDAQ: ZLAB), Notable Labs, Ltd. (NASDAQ: NTBL), Cardiff Oncology, Inc. (NASDAQ: CRDF), Johnson & Johnson (NYSE: JNJ). Research Nester concluded: "The pancreatic cancer market in North America is garner the largest revenue by the end of 2036 due to several demographic changes, including an aging population and increased incidence of obesity and diabetes. In the US, there are 37.3 million diabetics (11.3[R3] % of the population); 28.7 million are diagnosed with diabetes, including 28.5 million adults. As the population ages, there will be a higher prevalence of chronic diseases such as diabetes and obesity, which are risk factors for pancreatic cancer. Additionally, the aging population will lead to an increase in the number of people with pre-existing conditions that can increase the risk of developing pancreatic cancer. Obesity and diabetes are known risk factors for pancreatic cancer, and as these conditions become more prevalent, the number of cases of pancreatic cancer is expected to increase." Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) Receives Regulatory Clearance to Evaluate Pelareorep in Combination with Modified FOLFIRINOX +/- an anti-PD-L1 Inhibitor in Pancreatic Cancer US$5 million PanCAN grant provides important support for the fifth cohort of the GOBLET study Study of modified OLFIRINOX/pelareorep/atezolizumab (Tecentriq ®) combination expands existing pancreatic cancer program First patient expected to be enrolled in Q2 2024 Oncolytics Biotech ® Inc., a leading clinical-stage company specializing in immunotherapy for oncology, will commence enrollment into a new GOBLET study pancreatic cancer cohort following both German regulatory and ethics approvals. This cohort will evaluate pelareorep in combination with modified FOLFIRINOX (mFOLFIRINOX) with or without the PD-L1 immune checkpoint inhibitor atezolizumab (Tecentriq ® ) in newly diagnosed patients with pancreatic ductal adenocarcinoma (PDAC). It is supported by a US$5M Therapeutic Accelerator Award from the Pancreatic Cancer Action Network (PanCAN), an innovative program established to accelerate the development of new treatments for pancreatic cancer. The chemotherapy regimens of mFOLFIRINOX or gemcitabine + nab-paclitaxel are the two most common standards of care for pancreatic cancer. Oncolytics has already reported data with the combination of gemcitabine and nab-paclitaxel ( link to the PR , link to the poster ) that surpassed historical outcomes. Positive results from a combination with mFOLFIRINOX could greatly enhance pelareorep's potential in addressing pancreatic cancer. "Oncolytics is pleased to announce receipt of regulatory clearance to initiate the mFOLFIRINOX cohort in patients with newly diagnosed metastatic PDAC. We appreciate the opportunity to collaborate with PanCAN, Roche, and AIO on this cohort, which is expected to initiate enrollment in the second quarter," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "We believe that working with PanCAN will help to further enrich Oncolytics' clinical relationships with the pancreatic cancer community. We are also grateful for PanCAN's Therapeutic Accelerator Award, which is enabling the evaluation of this combination therapy." "The Therapeutic Accelerator Award program has been an important part of PanCAN's approach to advancing innovative treatments for pancreatic cancer. We incorporated input from leading scientists and clinicians in the field of pancreatic cancer to select Oncolytics as a recipient of this award," said Anna Berkenblit , MD, MMSc, Chief Scientific and Medical Officer at PanCAN. "Increasing patient access to clinical trials is vital to developing improved treatment options, so we are pleased that Oncolytics has received regulatory clearance for the pelareorep/mFOLFIRINOX combination and is poised to enroll the first patient in this cohort. We hope that the results from this study lead to improved outcomes for patients with pancreatic cancer." Dirk Arnold , M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial, commented, "Oncolytics has taken a very strategic approach to the development of pelareorep in pancreatic cancer by focusing its clinical studies on combinations with the most widely used treatment regimens. My experience to date with the GOBLET study, including the positive metastatic PDAC and encouraging anal cancer data reported last year, makes me enthusiastic to initiate enrollment in the mFOLFIRINOX cohort." "We previously reported very encouraging results in pancreatic cancer patients for the combination of pelareorep, gemcitabine/nab-paclitaxel, and atezolizumab, and we plan to begin a registration-enabling study of this regimen later this year. The new pelareorep/mFOLFIRINOX cohort offers the opportunity to expand pelareorep's role in pancreatic cancer. If the mFOLFIRINOX combination shows a compelling efficacy signal, this therapeutic approach could also be advanced to a registration-enabling study, providing two opportunities for pelareorep-based treatment to benefit pancreatic cancer patients," said Thomas Heineman , M.D., Ph.D., Chief Medical Officer at Oncolytics. "In addition, translational research studies planned for this cohort will help to further elucidate pelareorep's mechanism of action, including its ability to shape the tumor microenvironment (TME). Notably, we will evaluate the correlation between tumor responses and the expansion of tumor-infiltrating lymphocytes (TILs) in the blood, an effect that was observed in earlier pancreatic cancer studies. We look forward to initiating enrollment into the mFOLFIRINOX/pelareorep study cohort in the second quarter of this year." CONTINUED… Read these full press releases and more news for ONCY at: Other recent developments in the biotech industry of note for cancer events include: Zai Lab Limited (NASDAQ: ZLAB) recently announced financial results for the first quarter of 2024, along with recent product highlights and corporate updates. "Our first quarter results demonstrate strong commercial execution and pipeline progress across our potential first- and best-in-class product portfolio," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The launch of VYVGART is off to an impressive start with $13.2 million of sales in the first quarter. Looking ahead, we expect to accelerate commercial performance for the remainder of the year and are preparing for three new potential launches in 2024. We are also excited by the progress of our late-stage pipeline and we are on track to achieve the objectives outlined in our five-year strategic plan, including significant revenue growth and profitability by the end of 2025." "Our net revenues grew 39% y-o-y or 43% y-o-y at CER in the first quarter, driven by strong execution with the launch of VYVGART and uptake of our existing portfolio," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "With VYVGART's launch in gMG at the end of last year, and multiple new products and indications expected to launch over the near-term, we are now entering a period of robust growth for Zai Lab. Our significant growth, coupled with our focus on driving efficiencies and productivity across the organization, will drive the evolution of Zai Lab into a profitable, high growth business by the end of 2025. Furthermore, we will continue to focus on expanding our global portfolio through our internal discovery activities and strategic business development," Mr. Smiley concluded. Notable Labs, Ltd. (NASDAQ: NTBL), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive Precision Medicine Platform (PPMP), recently reported financial results for the year ended December 31, 2023 and provided a business update. "The last year has been a time of great accomplishment for Notable. We built a strong clinical validation dataset, starting with a poster presented at the American Association for Cancer Research (AACR 2023); became a publicly listed company, following the closing of a reverse merger in October 2023; and reported successful PPMP clinical data from the Phase 2 fosciclopirox study that showcased the ability of our platform to accurately predict patient outcomes for specific therapeutics," said Thomas Bock, M.D., Chief Executive Officer of Notable. "The performance of our platform in accurately predicting the outcome of the fosciclopirox study has enabled us to enhance the clinical trial plan for our lead product candidate, volasertib, in development for patients with relapsed/refractory acute myeloid leukemia (r/r AML). In our upcoming Phase 2 trial, we will be utilizing the platform to enrich the study's enrollment with patients predicted to respond to volasertib, which we believe will result in more rapid enrollment, shorter time to efficacy data and, ultimately, increased probability of success." Cardiff Oncology, Inc. (NASDAQ: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, recently announced financial results for the first quarter ended March 31, 2024, and provided a business update. "During the start of 2024, we presented several important new data sets supporting our first-line RAS-mutated mCRC strategy and the broader opportunity for onvansertib," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The data from the ONSEMBLE trial replicated, in a second independent and randomized dataset, the bev naïve signal from our earlier Phase 1b/2 KRAS-mutated mCRC trial. And the Phase 1b data published in the peer-reviewed journal Clinical Cancer Research, and the additional data we presented in one of our five posters at AACR, further substantiated our lead program in RAS-mutated mCRC. The additional AACR posters also point toward new indications for onvansertib in RAS wild-type mCRC, small cell lung cancer and ovarian cancer. Looking ahead, we believe that our upcoming data readout from our first-line trial in RAS-mutated mCRC has the potential to serve as a key value inflection point for our company and revolutionize the treatment of RAS-mutated mCRC, an area with no new treatments approved in over two decades." Johnson & Johnson (NYSE: JNJ) recently announced that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse. FDA approval is based on positive results from the Phase 3 CARTITUDE-4 study, which demonstrated that the earlier use of CARVYKTI® reduced the risk of disease progression or death by 59 percent compared to standard therapies—pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd)—in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy. The study, which was presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, also included and reported key secondary results such as overall response (OR) and overall survival (OS). 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- In RAS-mutated mCRC, clinical data from ONSEMBLE trial, and preclinical data presented at AACR, demonstrated strong efficacy signal in bev naïve patients and support ongoing first-line RAS-mutated mCRC lead program - - In RAS wild-type mCRC, preclinical data presented at AACR demonstrated onvansertib’s antitumor activity both as a single agent and in combination, highlighting its broad activity across all mCRC - - In SCLC and ovarian cancer, preclinical data presented at AACR highlighted onvansertib’s activity in combination treatments - - Cash and equivalents of $67 million as of March 31, 2024, projected runway into Q3 2025 - - Company will hold a conference call today at 4:30 p.m. ET/1:30 p.m. PT - SAN DIEGO, May 02, 2024 (GLOBE NEWSWIRE) -- Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced financial results for the first quarter ended March 31, 2024, and provided a business update. “During the start of 2024, we presented several important new data sets supporting our first-line RAS-mutated mCRC strategy and the broader opportunity for onvansertib,” said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. “The data from the ONSEMBLE trial replicated, in a second independent and randomized dataset, the bev naïve signal from our earlier Phase 1b/2 KRAS-mutated mCRC trial. And the Phase 1b data published in the peer-reviewed journal Clinical Cancer Research, and the additional data we presented in one of our five posters at AACR, further substantiated our lead program in RAS-mutated mCRC. The additional AACR posters also point toward new indications for onvansertib in RAS wild-type mCRC, small cell lung cancer and ovarian cancer. Looking ahead, we believe that our upcoming data readout from our first-line trial in RAS-mutated mCRC has the potential to serve as a key value inflection point for our company and revolutionize the treatment of RAS-mutated mCRC, an area with no new treatments approved in over two decades.” Upcoming expected milestones The Company has updated its expectation of the timing for an initial readout from the first-line RAS-mutated metastatic colorectal cancer (mCRC) randomized CRDF-004 trial to 2H 2024, based on the enrollment trends observed from active clinical trial sites. Company highlights for the quarter ended March 31, 2024 and subsequent weeks include: Presented updated data at AACR Annual Meeting 2024 that supports ongoing first-line RAS-mutated mCRC clinical study. In a poster titled “A Phase 1b/2 Clinical Study of Onvansertib in Combination with FOLFIRI/Bev Revealed a New Role of PLK1 in regulating the Hypoxia Pathway in KRAS-mutated mCRC,” updated clinical and preclinical data further supported the ongoing CRDF-004 Phase 2 trial of onvansertib + chemo/bev for the first-line treatment of RAS-mutated mCRC patients, who by definition are bev naïve.In vitro, onvansertib inhibited activation of the hypoxia pathway through the regulation of transcription factor HIF1α and its downstream targets.Bev naïve patients treated with onvansertib + FOLFIRI/bev demonstrated a significantly greater overall response rate [odds ratio=13.64, p<0.001] and longer PFS [hazard ratio=0.21, p=0.003] compared to bev exposed patients. Announced first patient dosed for lead program in randomized first-line Phase 2 trial, CRDF-004, for patients with RAS-mutated mCRC. The trial, whose clinical execution is being conducted by our partner, Pfizer Ignite, is designed to confirm the dose of onvansertib for a subsequent registrational trial, and generate safety and efficacy data for onvansertib when added to standard of care (SoC) vs. SoC alone.Interim topline results from CRDF-004 are expected in 2H 2024. Contingent upon the results, Cardiff Oncology will initiate a Phase 3, randomized trial, CRDF-005, with registrational intent. Provided a clinical update on Phase 2 randomized second-line ONSEMBLE trial in mCRC. New clinical data from second-line randomized ONSEMBLE trial, that closed for enrollment in 2023, provide further evidence of onvansertib’s role in improving the efficacy of SoC (FOLFIRI+bev) therapy in bev naïve patients.In the trial (n = 21), patients who were bev naïve and who received onvansertib in combination with SoC demonstrated an objective response rate (ORR) of 50% (2 of 4). No clinical responses were observed in bev naïve patients who received SoC alone (n = 3), or patients who were previously exposed to bev (n = 14).The ONSEMBLE data serves as a second independent, randomized, prospective data set providing evidence of the strong efficacy signal in bev naïve patients. Announced the publication of data from Phase 1b study in second line KRAS-mutated mCRC in the peer-reviewed journal Clinical Cancer Research. Findings from the Phase 1b portion of company's Phase 1b/2 study in second-line KRAS-mutated mCRC highlight the safety and promising efficacy of onvansertib in combination with SoC.These peer-reviewed published data are part of the Phase 1b/2 data announced in August 2023 and informed the shift to investigation in first-line RAS-mutated mCRC (CRDF-004). Presented three posters at AACR Annual Meeting 2024 in therapeutic areas outside of RAS-mutated mCRC In a poster titled “The PLK1 Inhibitor Onvansertib is Active as Monotherapy and in Combination with Cetuximab in RAS Wild-type mCRC Patient-derived Xenografts,” single agent onvansertib successfully induced tumor stasis or regression in 70% (14/20) of the RAS wild-type mCRC patient-derived xenograft (PDX) models tested which included both models sensitive to cetuximab (5/7, 71%) and resistant to cetuximab (9/13, 69%). Additionally, onvansertib in combination with cetuximab induced tumor stasis or regression in 90% (18/20) of the models tested. The antitumor activity of the combination was superior compared to monotherapy with either agent in both cetuximab sensitive and resistant models.In a poster titled “The PLK1 Inhibitor, Onvansertib, Synergizes with Paclitaxel in Small Cell Lung Cancer (SCLC),” onvansertib in combination with paclitaxel was well-tolerated and demonstrated superior efficacy over monotherapies in cisplatin sensitive and resistant SCLC PDX models. These preclinical findings in SCLC and previous data generated in breast cancer suggest that onvansertib in combination with paclitaxel has the potential to become a highly promising combination strategy across multiple cancer indications.In a poster titled “In vivo anti-tumor activity of onvansertib, a PLK1 inhibitor, combined with gemcitabine or carboplatin in platinum-resistant ovarian carcinoma patient-derived xenograft models,” onvansertib was synergistic in vitro in both combinations in an ovarian cancer cell line. Both combinations demonstrated antitumor activity in vivo in platinum-resistant ovarian cancer PDX models and was well tolerated. These data support the potential of onvansertib to improve SoC treatments for platinum-resistant ovarian cancer patients. First Quarter 2024 Financial Results Liquidity, cash burn, and cash runway As of March 31, 2024, Cardiff Oncology had approximately $67.2 million in cash, cash equivalents, and short-term investments. Net cash used in operating activities for the first quarter of 2024 was approximately $7.7 million, a decrease of approximately $1.0 million from $8.7 million for the same period in 2023. Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q3 of 2025. Operating results Total operating expenses were approximately $11.1 million for the three months ended March 31, 2024, a decrease of $1.0 million from $12.1 million for the same period in 2023. The decrease in operating expenses was primarily due to a reduction in chemistry, manufacturing and controls costs compared to the prior period. Conference Call and Webcast Cardiff Oncology will host a corresponding conference call and live webcast at 4:30 p.m. ET/1:30 p.m. PT on May 2, 2024. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company's website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company's website following the completion of the call. About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition, a well-validated oncology drug target, to develop novel therapies across a range of cancers. The Company's lead asset is onvansertib, a PLK1 inhibitor being evaluated in combination with standard of care (SoC) therapeutics in clinical programs targeting indications such as RAS-mutated metastatic colorectal cancer (mCRC), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC) and triple negative breast cancer (TNBC). These programs and the Company's broader development strategy are designed to target tumor vulnerabilities in order to overcome treatment resistance and deliver superior clinical benefit compared to the SoC alone. For more information, please visit https://www.cardiffoncology.com. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Cardiff Oncology's expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including the outbreak of an epidemic or pandemic such as the COVID-19 coronavirus and cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology's Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances. Cardiff Oncology Contact:James LevineChief Financial Officer858-952-7670jlevine@cardiffoncology.com Investor Contact:Kiki Patel, PharmD Gilmartin Group332-895-3225Kiki@gilmartinir.com Media Contact:Grace SpencerTaft Communications609-583-1151grace@taftcommunications.com Cardiff Oncology, Inc.Condensed Statements of Operations(in thousands, except for per share amounts)(unaudited) Three Months Ended March 31, 2024 2023 Royalty revenues$205 $83 Costs and expenses: Research and development 8,008 9,052 Selling, general and administrative 3,130 3,083 Total operating expenses 11,138 12,135 Loss from operations (10,933) (12,052) Interest income, net 926 940 Other income (expense), net (4) (111)Net loss (10,011) (11,223)Preferred stock dividend (6) (6)Net loss attributable to common stockholders$(10,017) $(11,229) Net loss per common share — basic and diluted$(0.22) $(0.25) Weighted-average shares outstanding — basic and diluted 44,678 44,677 Cardiff Oncology, Inc.Condensed Balance Sheets(in thousands)(unaudited) March 31, 2024 December 31, 2023Assets Current assets: Cash and cash equivalents$18,658 $21,655Short-term investments 48,529 53,168Accounts receivable and unbilled receivable 393 288Prepaid expenses and other current assets 2,410 2,301Total current assets 69,990 77,412Property and equipment, net 1,199 1,238Operating lease right-of-use assets 1,574 1,708Other assets 1,275 1,279Total Assets$74,038 $81,637 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable$5,191 $1,966Accrued liabilities 5,956 7,783Operating lease liabilities 696 691Total current liabilities 11,843 10,440Operating lease liabilities, net of current portion 1,301 1,458Total Liabilities 13,144 11,898 Stockholders’ equity 60,894 69,739Total liabilities and stockholders’ equity$74,038 $81,637 Cardiff Oncology, Inc.Condensed Statements of Cash Flows(in thousands)(unaudited) Three Months Ended March 31, 2024 2023 Operating activities Net loss$(10,011) $(11,223)Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 102 90 Stock-based compensation expense 1,124 1,064 Accretion of discounts on short-term investments, net (156) (163)Changes in operating assets and liabilities 1,201 1,573 Net cash used in operating activities (7,740) (8,659) Investing activities: Capital expenditures (80) (8)Net purchases, maturities and sales of short-term investments 4,716 7,337 Net cash provided by investing activities 4,636 7,329 Financing activities: Proceeds from exercise of options 107 — Net cash provided by financing activities 107 — Net change in cash and cash equivalents (2,997) (1,330)Cash and cash equivalents—Beginning of period 21,655 16,347 Cash and cash equivalents—End of period$18,658 $15,017